Use of Myoinositol in patients with Polycystic Ovary Syndrome who will undergo a procedure to try to get pregnant

Myoinositol as adjuvant therapy in patients with Polycystic Ovary Syndrome undergoing Assisted Reproduction procedures

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-557c2cz

Enrollment

Unknown

Registered

2024-07-15

Start date

2024-08-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Interventions

This is a randomized controlled trial and double-blind study with an expected sample of 124 women with Polycystic Ovary Syndrome (PCOS) who will undergo In Vitro Fertilization (IVF). Patients who meet

D02.033.800.519

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Women; between 18 and 40 years of age; with a body mass index between 18 and 34,9 kg/m2; diagnosed with Polycystic Ovary Syndrome according to the Rotterdam criteria; diagnosed with marital infertility according to the World Health Organization criteria; who agree to sign the Term of Free and Informed Consent

Exclusion criteria

Exclusion criteria: Presence of other diseases that cause hyperandrogenism (non classic congenital adrenal hyperplasia, hyperprolactinemia, thyroid diseases without adequate control, androgen secreting tumors, Cushing's Syndrome); Type 1 diabetes

Design outcomes

Primary

Measure	Time frame
It is expected to find a 25% increase in the cumulative clinical pregnancy rate, assessed by visualizing an embryo with the presence of a heartbeat in the seventh week of gestation on pelvic ultrasound examination.	—

Secondary

Measure	Time frame
Evaluate the improvement in metabolic parameters through serum testosterone, glucose and insulin measurements after three months of medication use. A decrease of at least 5% of the initial value is expected.;An improvement in oocyte quality is expected, assessed following the Istanbul Consensus criteria, with at least 10% more mature oocytes in the experimental group. ;A fertilization rate at least 10% higher is expected in the experimental group, with this rate being evaluated by the proportion between the number of oocytes with two pronuclei and two polar bodies over the number of injected oocytes.;An improvement in embryonic quality is expected, assessed following the Istanbul Consensus criteria, with at least 5% more embryos with the best classification.	—

Measure

Time frame

Evaluate the improvement in metabolic parameters through serum testosterone, glucose and insulin measurements after three months of medication use. A decrease of at least 5% of the initial value is expected.;An improvement in oocyte quality is expected, assessed following the Istanbul Consensus criteria, with at least 10% more mature oocytes in the experimental group. ;A fertilization rate at least 10% higher is expected in the experimental group, with this rate being evaluated by the proportion between the number of oocytes with two pronuclei and two polar bodies over the number of injected oocytes.;An improvement in embryonic quality is expected, assessed following the Istanbul Consensus criteria, with at least 5% more embryos with the best classification.

—

Countries

Brazil

Contacts

Public ContactMarina Keller

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

marinackeller@usp.br+55-16-36022816

Outcome results

None listed

Source: REBEC (via WHO ICTRP)